U.S. Drug Supply Chain Security Act (DSCSA)
The DSCSA aims to ensure counterfeit, stolen, contaminated, or otherwise harmful drugs do not enter the U.S. drug supply chain. It requires an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.
When the law goes into effect, it will fundamentally change how pharmaceutical companies do business in the United States. And though the U.S. Food and Drug Administration on August 25, 2023, announced an extended stabilization period that will be in effect until November 27, 2024, giving the industry more time to comply, all stakeholders should continue vigorously preparing to comply.
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Who has to comply with the DSCSA?
- Manufacturers
- Wholesale distributors
- Repackagers
- Dispensers (pharmacies, healthcare systems)
- Third-party logistics providers (3PLs)
The “Four Cornerstones” of DSCSA Compliance
Product identification (serialization)
Manufacturers and repackagers must put a unique product identifier (PI), such as a bar code, on certain prescription drug packages. This must be able to be read electronically.
Product tracing
Manufacturers, wholesale distributors, repackagers, and many dispensers (primarily pharmacies) must provide certain information about drug and who handled it each time it’s sold:
- Transaction information (TI) includes the product name; its strength and dosage form; its National Drug Code (NDC); container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred.
- The transaction statement (TS) is a paper or electronic attestation by the business transfer-ring ownership of the product that it has com-plied with the DSCSA.
- A third type of information, Transaction history (TH), is an electronic statement with the TI for every transaction going back to the manufacturer. It is required before the November 27, 2023, deadline; it is not required after that date.
Verification
Manufacturers, wholesale distributors, repackagers, and dispensers must establish systems and processes to verify PIs for certain prescription drugs packages. For saleable returns, manufacturers and wholesale distributors must use the Verification Router Service (VRS).
Authorized trading partners (ATPs)
All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers must be ATPs and be able to electronically verify that their trading partners are ATPs.
Our solutions
Serialization Management
Event-based serialization management complies with regulations, including Product Identifiers (PIs) under the DSCSA.
Compliance Mangement
Meet requirements from regulators and trading partners for reporting, sharing, and exchanging product data.
Exceptions Handling
Ensure your EPCIS data for every product is DSCSA-compliant; quickly find and resolve data quality issues across your entire supply chain.
Authorized Trading Partners (ATPs)
Integrated solutions to automatically verify ATP status through leading providers Spherity and LedgerDomain.
Verification Router Service (VRS)
Automate verification of saleable returns and achieve sub-second request/response times with trading partners.
Traceability System
Track and trace of serialized products for complete supply chain visibility.
EPCIS
Full compliance with electronic, interoperable data exchange requirements using EPCIS.
EDGE Solutions
Manage serialized data for handling warehouse operations (receive, pick, pick/pack, ship). Support aggregation of serialized packages.
Our industry leadership efforts
- VRS Network: Led FDA-approved pilot for VRS readiness and to extend performance testing of the network
- DSCSA 2023 Plan: Chairing Healthcare Distribution Alliance (HDA) Working Group to define industry plan for 2023
- PDG ATP Initiatives: Founding member of the Partnership for DSCSA Governance (PDG) Open Credentialing Initiative (OCI); only provider in three ATP pilots
- EPCIS Center of Excellence: Developing processes to accelerate EPCIS rollout and ensure proper exchange of data
DSCSA Milestones & Requirements
2013
NOV. 27, 2013
DSCSCA is enacted.
2014
NOV. 27, 2014
Third-party logistics provider (3PLs) must report licensure information to FDA annually.
2015
JAN. 21, 2015
All trading partners must be authorized.
Manufacturers must print lot numbers of packaging for all prescription drugs.
2015
JULY 1, 2015
Dispensers must provide T3 information to trading partners.
2017
NOV. 27, 2017
Manufacturers must serialize and verify products.
2018
NOV. 27, 2018
Repackagers must serialize products — associate and verify serial numbers.
2019
NOV. 27, 2019
Wholesale distributors can receive & distribute only serialized products.
Wholesale distributors must verify SNIs, including saleable returns.
2020
OCT. 23, 2020
FDA delays enforcement of saleable returns requirement by 1 year for wholesale distributors and dispensers.
2023
AUG. 25, 2023
FDA announces “extended stabilization period,” postponing DSCSA enforcement by 1 year.
2024
NOV. 27, 2024
Full interoperable electronic unit-level traceability for all supply chain actors.
Dispensers only receive and ship/dispense serialized products.
Dispensers verify Product Identifiers, including standardized numerical identifier (SNIs).
Why we’re different
We’re the longest-tenured compliance and track and trace solutions provider in the life sciences industry. Our digital supply chain solutions will ensure you’ll meet all DSCSA requirements — plus the requirements of all other global regulations, such as the EU Falsified Medicines Directive (FMD), Russia’s National Track and Trace Digital System (Chestny ZNAK), and Brazil’s Health Regulatory Agency (ANVISA).
We will also help you:
- Safeguard your products and brand
- Ensure patients get the right drug at the right time
- Combat counterfeit drugs
- Secure your business investments
